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Evaluation of Institutional Review Board Review and Informed Consent in Publications of Human Research in Critical Care Medicine

Author

Matot, Idit

Pizov, Reuven

Sprung, Charles L.

Bibliographic Citation

Critical Care Medicine. 1998 Sep; 26(9): 1596-1602.

Abstract

OBJECTIVE: To examine the frequency of obtaining Institutional Review
Board (IRB) approval and informed consent in critical care research. DATA
SOURCES AND DATA EXTRACTION: One-year retrospective review of original
critical care research in humans published in seven journals, including
American Journal of Respiratory and Critical Care Medicine, Chest, Critical
Care Medicine, Intensive Care Medicine, The Journal of the American Medical
Association, Lancet, and The New England Journal of Medicine. Studies were
examined for general information (country/state where the research was
performed, affiliation of the hospital to a medical school, and whether the
work was supported by a grant and specifically by a pharmaceutical company),
approval by IRB, method of consent, design of research, and interventions
involved in the study. DATA SYNTHESIS: Two hundred seventy-nine studies were
reviewed, 124 (44%) of which were conducted in the United States. Two hundred
forty-three (87%) studies were performed in a university institution, 96 (34%)
studies were supported by a grant, and 23 (24%) studies were supported by a
pharmaceutical company. In 66 (24%) studies, there was no evidence of IRB
review and informed consent approval. IRB approval was obtained but the method
of consent was not specified in 36 (13%) studies. No significant differences
were found in obtaining IRB approval and informed consent between research
conducted in the United States (n=71, 57%) or outside the United States (n=92,
59%). Grant support was obtained in ten (9%) of the 116 studies not fully
approved, compared with 70 (50%) of the 140 studies that obtained full
approval (p less than .05). All studies (23) supported by the pharmaceutical
industry were fully approved. CONCLUSIONS: Many published studies in critical
care lack IRB approval and/or informed consent. All research supported by the
pharmaceutical industry was fully approved. The findings raise ethical
concerns about critical care research.